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Nab-docetaxel in metastatic breast cancer
NCT00531271Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2007
- Primary completion
- Dec 2008
- Countries
- 1
- Sponsor
- Celgene Corporation
- Modality
- Nanoparticles, Small Molecules
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of albumin-bound docetaxel in breast cancer, sponsored by Celgene Corporation. Primary endpoints: Maximum Tolerated Dose and Dose Limiting Toxicities. Started Nov 2007; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
ABI-008 Arm
Patients receive ABI-008 (nab-docetaxel) at doses ranging from 60 to 200 mg/m2 via intravenous infusion every 3 weeks.
03
Endpoints
Primary
Maximum Tolerated Dose
Dose Limiting Toxicities
Secondary
Safety and Tolerability
Pharmacokinetic Parameters
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